Cleared Traditional

SERODIA ATG

K953066 · Fujirebio America, Inc. · Immunology

Aug 1995

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K953066 is an FDA 510(k) clearance for the SERODIA ATG, a Thyroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDC), submitted by Fujirebio America, Inc. (West Cadwell, US). The FDA issued a Cleared decision on August 14, 1995, 45 days after receiving the submission on June 30, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number	K953066 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 1995
Decision Date	August 14, 1995
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement